Xgeva Generic Name & Formulations
Legal Class
Rx
General Description
Denosumab 120mg/1.7mL (70mg/mL); soln for SC inj; preservative-free.
Pharmacological Class
Osteoclast inhibitor (RANKL inhibitor).
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Xgeva Indications
Indications
Treatment of adults and skeletally-mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
Xgeva Dosage and Administration
Adult
Give by SC inj into upper arm, upper thigh, or abdomen. 120mg once every 4 weeks with additional 120mg doses on Days 8 and 15 of the 1st month of therapy.
Children
Not established (interferes with bone growth and dentition).
Xgeva Contraindications
Contraindications
Pre-existing hypocalcemia.
Xgeva Boxed Warnings
Not Applicable
Xgeva Warnings/Precautions
Warnings/Precautions
Correct hypocalcemia before starting; ensure adequate daily calcium, magnesium, and Vit.D intake, esp. in renal impairment (CrCl <30mL/min). Monitor calcium (esp. 1st weeks of initiating), phosphorus, magnesium levels and Vit.D intake in susceptible patients (eg, severe renal impairment, receiving dialysis). Risk of osteonecrosis of the jaw (ONJ) in diabetes, gingival infections. Perform oral exam and preventive dentistry before and regularly during therapy. Maintain good oral hygiene. Avoid invasive dental procedures during treatment; consider temporary discontinuation if procedure is necessary. Evaluate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Monitor for hypercalcemia after treatment discontinuation in patients with giant cell tumor of the bone and patients with growing skeletons. Risk for or history of osteoporosis or prior fractures: increased risk of multiple vertebral fractures after discontinuing treatment. Embryo-fetal toxicity. Advise females of reproductive potential to use highly effective contraception during therapy and for at least 5 months after last dose. Pregnancy; exclude status prior to initiation. Nursing mothers (impaired mammary gland development/lactation in animal studies).
REMS
NO, but Prolia, another product containing denosumab, does.
Xgeva Pharmacokinetics
See Literature
Xgeva Interactions
Interactions
Concomitant other denosumab-containing products (eg, Prolia): not recommended. Concomitant calcimimetics and other drugs that can lower calcium levels; monitor. Increased risk of ONJ with concomitant corticosteroids, immunosuppressants, angiogenesis inhibitors or duration of denosumab exposure.
Xgeva Adverse Reactions
Adverse Reactions
Fatigue, asthenia, hypophosphatemia, nausea, arthralgia, headache, back pain, pain in extremity, dyspnea, decreased appetite, peripheral edema, vomiting, anemia, constipation, diarrhea, thrombocytopenia, upper RTI, rash; ONJ, hypocalcemia (may be fatal), hypersensitivity reactions (discontinue if occur).
Xgeva Clinical Trials
See Literature
Xgeva Note
Not Applicable
Xgeva Patient Counseling
See Literature
Xgeva Generic Name & Formulations
Legal Class
Rx
General Description
Denosumab 120mg/1.7mL (70mg/mL); soln for SC inj; preservative-free.
Pharmacological Class
Osteoclast inhibitor (RANKL inhibitor).
How Supplied
Single-dose vial—1
Manufacturer
Generic Availability
NO
Xgeva Indications
Indications
Prevention of skeletal-related events (SRE) in patients with multiple myeloma and in patients with bone metastases from solid tumors. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.
Xgeva Dosage and Administration
Adult
Give by SC inj into upper arm, upper thigh, or abdomen. SRE: 120mg once every 4 weeks. Hypercalcemia: 120mg once every 4 weeks with additional 120mg doses on Days 8 and 15 of the 1st month of therapy.
Children
Not established (interferes with bone growth and dentition).
Xgeva Contraindications
Contraindications
Pre-existing hypocalcemia.
Xgeva Boxed Warnings
Not Applicable
Xgeva Warnings/Precautions
Warnings/Precautions
Correct hypocalcemia before starting; ensure adequate daily calcium, magnesium, and Vit.D intake, esp. in renal impairment (CrCl <30mL/min). Monitor calcium (esp. 1st weeks of initiating), phosphorus, magnesium levels and Vit.D intake in susceptible patients (eg, severe renal impairment, receiving dialysis). Risk of osteonecrosis of the jaw (ONJ) in diabetes, gingival infections. Perform oral exam and preventive dentistry before and regularly during therapy. Maintain good oral hygiene. Avoid invasive dental procedures during treatment; consider temporary discontinuation if procedure is necessary. Evaluate for atypical fractures if thigh/groin pain develops; consider withholding therapy until risk/benefit assessment. Monitor for hypercalcemia after treatment discontinuation in patients with giant cell tumor of the bone and patients with growing skeletons. Risk for or history of osteoporosis or prior fractures: increased risk of multiple vertebral fractures after discontinuing treatment. Embryo-fetal toxicity. Advise females of reproductive potential to use highly effective contraception during therapy and for at least 5 months after last dose. Pregnancy; exclude status prior to initiation. Nursing mothers (impaired mammary gland development/lactation in animal studies).
REMS
NO, but Prolia, another product containing denosumab, does.
Xgeva Pharmacokinetics
See Literature
Xgeva Interactions
Interactions
Concomitant other denosumab-containing products (eg, Prolia): not recommended. Concomitant calcimimetics and other drugs that can lower calcium levels; monitor. Increased risk of ONJ with concomitant corticosteroids, immunosuppressants, angiogenesis inhibitors or duration of denosumab exposure.
Xgeva Adverse Reactions
Adverse Reactions
Fatigue, asthenia, hypophosphatemia, nausea, arthralgia, headache, back pain, pain in extremity, dyspnea, decreased appetite, peripheral edema, vomiting, anemia, constipation, diarrhea, thrombocytopenia, upper RTI, rash; ONJ, hypocalcemia (may be fatal), hypersensitivity reactions (discontinue if occur).
Xgeva Clinical Trials
See Literature
Xgeva Note
Not Applicable
Xgeva Patient Counseling
See Literature